Oecd Series On Testing And Assessment Second Edition Guidance Document On Integrated Approaches To Testing And Assessment Iata For Serious Eye Damage And Eye Irritation
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Oecd Series On Testing And Assessment Second Edition Guidance Document On Integrated Approaches To Testing And Assessment Iata For Serious Eye Damage And Eye Irritation
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2019-07-25
Oecd Series On Testing And Assessment Second Edition Guidance Document On Integrated Approaches To Testing And Assessment Iata For Serious Eye Damage And Eye Irritation written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-25 with categories.
This document suggests an Integrated Approach on Testing and Assessment (IATA) for serious eye damage and eye irritation hazard identification. The document also provides key information characteristics of each of the individual information sources comprising the IATA. Furthermore it provides guidance on how and when to integrate existing and/or newly generated information for decision making, including decisions on the need for further testing or final decisions on classification and labelling regarding the potential eye hazard effects of test chemicals.
Risk Assessment For Environmental Health
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Author : Mark G. Robson
language : en
Publisher: CRC Press
Release Date : 2022-12-30
Risk Assessment For Environmental Health written by Mark G. Robson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-30 with Medical categories.
Understanding risk to humans is one of the most important problems in environmental public health. Risk assessment is constantly changing with the advent of new exposure assessment tools, more sophisticated models, and a better understanding of disease processes. Risk assessment is also gaining greater acceptance in the developing world where major environmental problems exist. Developed in partnership with the Association of Schools of Public Health, this comprehensive text offers a thorough survey of risk assessment, management, and communications as these practices apply to public health. Key Features: Provides a practical overview of environmental risk assessment and its application by discussing the process and providing case studies and examples Focuses on tools and approaches used for humans in an environment involving potential chemical hazards Fully updated, the first part introduces the underlying principles and techniques of the field, and the second examines case studies in terms of different risk assessment scenarios Risk assessment is a core requirement for the MPH degree in environmental health Useful “stories” suitable for case studies
Skin 3 D Models And Cosmetics Toxicity
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Author : Aditya Bhushan Pant
language : en
Publisher: Springer Nature
Release Date : 2023-08-28
Skin 3 D Models And Cosmetics Toxicity written by Aditya Bhushan Pant and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-28 with Medical categories.
Efforts are being made by research organizations and cosmetic industries worldwide to develop more precise and targeted 3D models that mimic humans for testing cosmetic and personal health care product ingredients, following a complete ban on animal testing. This book includes several subtopics dedicated to the progress made, challenges faced, roadblocks encountered, and future prospects in the development and validation of 3D models for testing these products. The book consist of an editorial and 14 themed chapters that will showcase the significant progress made so far, challenges encountered, and future prospects in the development of 3D reconstruct models.
Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 494 Vitrigel Eye Irritancy Test Method For Identifying Chemicals Not Requiring Classification And Labelling For Eye Irritation Or Serious Eye Damage
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2021-06-17
Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 494 Vitrigel Eye Irritancy Test Method For Identifying Chemicals Not Requiring Classification And Labelling For Eye Irritation Or Serious Eye Damage written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-17 with categories.
The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation potential of a test chemical based on its ability to induce damage to the barrier function of the human corneal epithelium (hCE) models used in the Vitrigel-EIT method. It is known that chemicals that are irritating to the eye first destroy tear film and epithelial barrier function of the eye, subsequently induce epithelial cell death, and finally produce stromal degeneration and endothelial cell death, resulting in corneal opacity. Therefore, the change of the epithelial barrier function is a relevant endpoint for detecting eye irritation. In the Vitrigel Eye Irritancy test method , time-dependent changes in the Transepithelial Electrical Resistance (TEER) values are indicative of damage to the barrier function of the corneal epithelium following exposure to a test chemical; this situation is similar to the observed damage of the rabbit cornea following exposure to a test chemical, which is an important mode of action leading to damage of the corneal epithelium and eye irritation. The Vitrigel-Eye Irritancy Test (EIT) method can be used within the limited applicability domain of test chemicals having pH > 5.0 (based on 2.5% weight/volume (w/v) preparation).
The History Of Alternative Test Methods In Toxicology
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Author :
language : en
Publisher: Academic Press
Release Date : 2018-10-20
The History Of Alternative Test Methods In Toxicology written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-20 with Medical categories.
The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.
Practical Handbook On The 3rs In The Context Of The Directive 2010 63 Eu
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Author : Gianni Dal Negro
language : en
Publisher: Academic Press
Release Date : 2021-11-18
Practical Handbook On The 3rs In The Context Of The Directive 2010 63 Eu written by Gianni Dal Negro and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-18 with Science categories.
Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide. - Closes a gap in scientific literature by addressing the need for clear guidance in walking through the multifaced universe of 3Rs - Offers a useful starting point for readers and scientist who approach the 3Rs for the first-time - Gives insights into the harmonization of the animal research legislation across countries
Drug Discovery And Evaluation Safety And Pharmacokinetic Assays
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Author : Franz J. Hock
language : en
Publisher: Springer Nature
Release Date : 2024-10-21
Drug Discovery And Evaluation Safety And Pharmacokinetic Assays written by Franz J. Hock and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-21 with Medical categories.
Many aspects of drug safety have become an outstanding and even persistent issue and may occur during the process of both drug discovery and development. Until 15 years ago, drug discovery and evaluation was primarily a sequential process starting with the selection of the most pharmacologically active compound from a series of newly synthesized small molecule chemical series by means of distinctive pharmacological assays. Safety aspects were addressed by evaluation of the selected compound at high doses in a series of specific studies directed at indications other than the intended indication of the new compound. These tests are then followed by pharmacokinetic studies, which are primarily conducted to confirm whether the selected compound possesses a suitable half-life for sufficient exposure and efficacy and, whether it has the desired properties specificity to the intended route of administration. Safety aspects relied predominantly on the conduct of single and repeat toxicologydose studies, which inform changes in organ structure rather than organ function. Both toxicological and pharmacokinetic studies are adapted to the progress of studies in clinical pharmacology and clinical trials. The new edition of this well and broadly accepted reference work contains several innovative and distinguished chapters. This "sequential" strategy has been abandoned with this new version of the book for several reasons: - Of the possible multitude of negative effects that novel drugs may impart on organ function, e.g. ventricular tachy-arrhythmia, many are detected too late in non-clinical studies to inform clinicians. On the other hand, negative findings in chronic toxicity studies in animals may turn out to be irrelevant for human beings. - New scientific approaches, e.g. high-throughput screening, human pluripotent stem cells, transgenic animals, knock-out animals, in silico models, pharmaco-genomics and pharmaco-proteomics, as well as Artificial Intelligence (AI) methods offered new possibilities. - There are several examples, that show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. Research and development scientists, involving the following changes, therefore adopted a change of strategy: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group and the Safety Pharmacology Society (SPS) was launched. The discipline provided for evaluation, development and validation of a multitude of safety tests outlined in the 'Core Battery of Studies'. - Characterizing the exposure profile of a drug by conducting pharmacokinetic studies that evaluates the absorption, distribution, metabolism and excretion should to be investigated at an early stage of development as results contribute to the selection of a compound for further development. Advancements in Toxicology were achieved by the introduction of new methods, e.g., in silico methods, genetic toxicology, computational toxicology and AI. The book is a landmark in the continuously changing world of drug research and developments. As such, it is essential reading for many groups: not only for all students of pharmacology and toxicology but also for industry scientists and physicians, especially those involved in clinical trials of drugs, and for pharmacists who must know the safety requirements of drugs. The book is essential for scientists and managers in the pharmaceutical industry who are involved in drug discovery, drug development and decision making in the development process. In particular, the book will be of use to government institutions and committees working on official guidelines for drug evaluation worldwide.
Toxicology And Risk Assessment
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Author : Helmut Greim
language : en
Publisher: John Wiley & Sons
Release Date : 2018-11-05
Toxicology And Risk Assessment written by Helmut Greim and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-05 with Science categories.
Provides a complete understanding of how our bodies respond to toxicants, and the principles used to assess the health risks of specific exposure scenarios Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition reflects recent advances in science and technology, and provides the scientific background and methodological issues to enable the reader to understand the basic principles in toxicology and to evaluate the health risks of specific exposure scenarios. Completely updated with the latest information, this book offers a concise introduction to the subject. It is divided into five sections: Principles in Toxicology, Organ Toxicology, Methods in Toxicology, Regulatory Toxicology, and Specific Toxicity. The 2nd Edition adds new chapters that cover recent scientific and technological advances and current topics including the endocrine system, alternatives to animal testing, risk assessment and thresholds for carcinogens, European and international regulation, nanomaterials, fuels, fragrances, and agrochemicals. Concentrates on the basic concepts of toxicology and provides sufficient information for the reader to become familiar with them in order to understand the principles and to evaluate the risks at given exposures 30% new chapters cover recent scientific and technological advances including alternatives to animal testing; genotoxic carcinogens; REACH regulations; nanomaterials; fuels; fragrances; PAHs; and agrochemicals Written by a team of international specialists, and edited by two outstanding scientists in the field Fully updated and expanded, Toxicology and Risk Assessment: A Comprehensive Introduction, Second Edition is an essential text for any student or researcher with an interest in toxicology and related risk assessments.
Oecd Guidelines For The Testing Of Chemicals Oecd Series On Testing And Assessment Guidance Notes For Analysis And Evaluation Of Chronic Toxicity And Carcinogenicity Studies
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2002-12-12
Oecd Guidelines For The Testing Of Chemicals Oecd Series On Testing And Assessment Guidance Notes For Analysis And Evaluation Of Chronic Toxicity And Carcinogenicity Studies written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-12-12 with categories.
These Guidance Notes outline core concepts in order to obviate the need to consult large numbers of text books, while still pointing the reader to sources of more detailed or specific information.
Lignes Directrices De L Ocde Pour Les Essais De Produits Chimiques Section 4 Essai No 494 M Thode D Essai Vitrigel Pour L Identification De Produits Chimiques Ne N Cessitant Aucune Classification Ni Tiquetage Pour Irritation Oculaire Ou L Sions Oculaires Graves
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Author : OECD
language : fr
Publisher: OECD Publishing
Release Date : 2021-06-17
Lignes Directrices De L Ocde Pour Les Essais De Produits Chimiques Section 4 Essai No 494 M Thode D Essai Vitrigel Pour L Identification De Produits Chimiques Ne N Cessitant Aucune Classification Ni Tiquetage Pour Irritation Oculaire Ou L Sions Oculaires Graves written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-17 with categories.
Le test d’irritation oculaire (TIO) Vitrigel est une méthode in vitro permettant d’identifier, sans essais supplémentaires, des produits chimiques testés ne nécessitant ni classification ni étiquetage pour irritation oculaire ou lésions oculaires graves. L’objectif de la présente Ligne directrice est de décrire les procédures utilisées pour évaluer le potentiel d’irritation oculaire que présente un produit chimique testé en se fondant sur sa capacité́ à réduire la fonction de barrière de modèles d’épithélium cornéen humain (ECh) utilisés dans le TIO Vitrigel. Il est connu que les produits chimiques irritants pour l’œil détruisent d’abord le film lacrymal et la fonction de barrière de l’épithélium cornéen, avant d’induire la mort des cellules épithéliales et, enfin, une dégénérescence du stroma et la mort des cellules endothéliales, ce qui provoque une opacité cornéenne. Pour cette raison, les changements de la fonction de barrière de l’épithélium constituent un effet mesuré pertinent pour détecter l’irritation oculaire. Dans le test d’irritation oculaire Vitrigel, les changements dans le temps de la valeur de la résistance électrique transépithéliale (Transepithelial Electrical Resistance – TEER) révèlent une perte de la fonction de barrière de l’épithélium cornéen suite à l’exposition à un produit chimique testé. Cette situation s’apparente aux lésions observées sur la cornée de lapin après exposition à un produit chimique testé et qui constituent un mode d’action important dans le processus de lésion de l’épithélium cornéen et d’irritation oculaire. Le test d’irritation oculaire (TIO) Vitrigel peut être utilisé dans un champ d’application limité aux produits chimiques ayant un pH > 5.0 (sur la base d’une préparation à 2,5 % (p/v)).